Status:
RECRUITING
Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins
Lead Sponsor:
Chengdu University of Traditional Chinese Medicine
Conditions:
Varicose Veins of Lower Limb
Venous Insufficiency of Leg
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.
Detailed Description
Chronic venous insufficiency (CVI) is a common clinical disease, and varicose veins of the lower extremities are the main clinical manifestations of CVI, and studies have shown that the prevalence of ...
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years and ≤90 years;
- Clinical diagnosis of primary varicose veins of the lower extremities, CEAP clinical classification C2-C6, requiring treatment of the great and/or small saphenous vein segments, and at least 1 of the clinical symptoms of swelling, pain, burning sensation, heaviness, easy fatigue, itchy skin, and night cramps;
- Valve insufficiency of the great saphenous vein, small saphenous vein, or transport vein;
- Doppler ultrasound confirmation of a saphenous vein diameter greater than 3 mm and less than 12 mm in the standing position;
- Only one limb per patient was selected for inclusion in the study;
- Patients signed an informed consent form and were willing to co-operate in completing the protocol-specified investigations and follow-up visits.
Exclusion Criteria:
- Thrombosis of the great saphenous or small saphenous vein, or combined deep vein thrombosis, or previous history of deep vein thrombosis or pulmonary embolism.
- Recurrent varicose veins after previous treatment.
- Severe distortion of the great saphenous vein with anticipated catheter failure.
- Severe lower limb ischaemia (CLI) (ABPI <0.8).
- Known allergy to medications and device materials involved in the study.
- Pre-existing implanted pacemaker, defibrillator, currently on regular anticoagulation therapy (e.g., warfarin, heparin).
- Women who are pregnant or breastfeeding.
- Unable or unwilling to complete the questionnaire.
- Participating in a study of another drug or device.
- Life expectancy <1 year.
- Those undergoing treatment for skin malignancies other than non-melanoma.
- Daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain due to venous disease.
- In the judgement of the investigator, endovenous therapy is not appropriate.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06711120
Start Date
December 1 2024
End Date
December 1 2025
Last Update
December 2 2024
Active Locations (1)
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1
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, China